1st January 2021: Serialisation of sales packs of all active pharmaceutical ingredient packs.

Tunisia

The Tunisia health authority are developing requirements.

UAE

The Dubai Health Authority have published requirements for a GS1 Datamatrix to be applied to all secondary packs sold to DHA(?) by 1st January 2017 containing batch variable data. They are no longer accepting unmarked product.

The three other health authorities in the UAE have yet to publish their requirements.

Companies can meet this requirement, at least in the short term, by having local converters apply appropriately marked stickers, although issues with the quality of these stickers have caused the HDA to require an additional barcode verification report to be sent with each shipment.

US DSCSA

The November 2017 deadline for serialising all product is approaching fast. Worryingly, there still seems to be a large proportion of smaller Pharma companies and contract manufacturers who have not made significant progress.

The need to aggregate product continues to be a significant debate.

The FDA, in a consultation workshop in October 2016, essentially stated that they will not be legislating on this and it was up to the supply chain to define what was necessary to meet the requirements.

The big wholesalers are calling for aggregation.

A significant number of manufacturers are planning to aggregate US product from day one.

Other manufacturers, in particular the generic companies, are not planning to aggregate and, in the case of the generic manufacturers, are pushing to never have too aggregate.

The HMA (wholesalers organisation) ran pilots in 2016, with one of the areas of focus being how they will be able to meet their 2019 requirements to authenticate product returned to them for sale. They concluded that two options are practical and pilots will run in 2017 to investigate them. The two models are:

Manufacturers reporting serialisation information to the wholesalers when product is shipped to them. This effectively moves much of the 2023 requirement on manufacturers forward to 2018/9.

The establishment of information exchange hub(s) to allow wholesalers to “ask” for real time authentication of packs they are holding. Like the EU hub, this system would have the advantage that each company only needs to connect to one system. However, there is a long way to go before such a system becomes real.

I wonder what, if any, impact President Trump’s desire for reduced regulation on industry will have on the DSCSA in the long term.

If you would like to discuss your particular situation with regard to aggregation, or other aspects of serialization, please do not hesitate to contact me at Stephen.McIndoe@be4ward.com